BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP BNP ASSAY

    MDR report key: 2250231 · Received September 15, 2011

    Report

    Report Number
    1219913-2011-00124
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NBC
    PMA / PMN Number
    K040425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY DISCORDANT HIGH ADVIA CENTAUR XP BNP TEST RESULTS IS UNKNOWN AND THE CUSTOMER HAS DECLINED A FIELD SERVICE INTERVENTION. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "THE RESULTS OF THE ADVIA CENTAUR BNP ASSAY SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR XP BNP RESULTS WERE OBTAINED BY THE CUSTOMER AND REPORTED ON TWO PATIENT SAMPLES. THE INITIAL RESULTS WERE DISCORDANT WHEN THE CUSTOMER CHANGED TO A NEW BNP LOT AND PERFORMED A LOT TO LOT COMPARISON STUDY. THE CUSTOMER PROVIDED A CORRECTED TEST RESULT FOR BOTH PATIENTS. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW ADVIA CENTAUR XP BNP ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP BNP ASSAY BNP IMMUNOASSAY NBC SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 157

    Patients

    Seq Age Sex Outcome Treatment
    1